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    Immune checkpoint inhibitors and targeted therapies have dramatically improved outcomes in patients with advanced melanoma, but approximately half these patients will not have a durable benefit. Phase 1-2 trials of adoptive cell therapy with tumor-infiltrating lymphocytes (TILs) have shown promising responses, but data from phase 3 trials are lacking to determine the role of TILs in treating advanced melanoma. In this phase 3, multicenter, open-label trial, we randomly assigned patients with unresectable stage IIIC or IV melanoma in a 1:1 ratio to receive TIL or anti-cytotoxic T-lymphocyte antigen 4 therapy (ipilimumab at 3 mg per kilogram of body weight). Infusion of at least 5×109 TILs was preceded by nonmyeloablative, lymphodepleting chemotherapy (cyclophosphamide plus fludarabine) and followed by high-dose interleukin-2. The primary end point was progression-free survival. A total of 168 patients (86% with disease refractory to anti-programmed death 1 treatment) were assigned to receive TILs (84 patients) or ipilimumab (84 patients). In the intention-to-treat population, median progression-free survival was 7.2 months (95% confidence interval [CI], 4.2 to 13.1) in the TIL group and 3.1 months (95% CI, 3.0 to 4.3) in the ipilimumab group (hazard ratio for progression or death, 0.50; 95% CI, 0.35 to 0.72; P<0.001); 49% (95% CI, 38 to 60) and 21% (95% CI, 13 to 32) of the patients, respectively, had an objective response. Median overall survival was 25.8 months (95% CI, 18.2 to not reached) in the TIL group and 18.9 months (95% CI, 13.8 to 32.6) in the ipilimumab group. Treatment-related adverse events of grade 3 or higher occurred in all patients who received TILs and in 57% of those who received ipilimumab; in the TIL group, these events were mainly chemotherapy-related myelosuppression. In patients with advanced melanoma, progression-free survival was significantly longer among those who received TIL therapy than among those who received ipilimumab. (Funded by the Dutch Cancer Society and others; number, NCT02278887.). Copyright © 2022 Massachusetts Medical Society.


    Maartje W Rohaan, Troels H Borch, Joost H van den Berg, Özcan Met, Rob Kessels, Marnix H Geukes Foppen, Joachim Stoltenborg Granhøj, Bastiaan Nuijen, Cynthia Nijenhuis, Inge Jedema, Maaike van Zon, Saskia Scheij, Jos H Beijnen, Marten Hansen, Carlijn Voermans, Inge M Noringriis, Tine J Monberg, Rikke B Holmstroem, Lidwina D V Wever, Marloes van Dijk, Lindsay G Grijpink-Ongering, Ludy H M Valkenet, Alejandro Torres Acosta, Matthias Karger, Jessica S W Borgers, Renske M T Ten Ham, Valesca P Retèl, Wim H van Harten, Ferry Lalezari, Harm van Tinteren, Astrid A M van der Veldt, Geke A P Hospers, Marion A M Stevense-den Boer, Karijn P M Suijkerbuijk, Maureen J B Aarts, Djura Piersma, Alfons J M van den Eertwegh, Jan-Willem B de Groot, Gerard Vreugdenhil, Ellen Kapiteijn, Marye J Boers-Sonderen, W Edward Fiets, Franchette W P J van den Berkmortel, Eva Ellebaek, Lisbet R Hölmich, Alexander C J van Akkooi, Winan J van Houdt, Michel W J M Wouters, Johannes V van Thienen, Christian U Blank, Aafke Meerveld-Eggink, Sebastian Klobuch, Sofie Wilgenhof, Ton N Schumacher, Marco Donia, Inge Marie Svane, John B A G Haanen. Tumor-Infiltrating Lymphocyte Therapy or Ipilimumab in Advanced Melanoma. The New England journal of medicine. 2022 Dec 08;387(23):2113-2125

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    PMID: 36477031

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